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Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Onconix, Inc
ClinicalTrials.gov Identifier:
NCT01371695
First received: June 9, 2011
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer.


Condition
Cervical Cancer
Cervical Intraepithelial Neoplasia II
Cervical Intraepithelial Neoplasia III

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 1 of Serum IGF II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Onconix, Inc:

Biospecimen Retention:   Samples With DNA

frozen serum


Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

university clinic

Criteria

Inclusion Criteria:

  • Age 18 - 75 years
  • Female
  • Normal medical history
  • Medical history of a single type of cancer confirmed by biopsy or equivalent criteria
  • Squamous cell carcinoma of organs other than cervix
  • Adenocarcinoma
  • Medical history of inflammatory disease
  • May be pregnant
  • Pap smear positive for Cervical Intraepithelial Neoplasia II or III
  • Squamous cell cervical cancer confirmed by biopsy
  • Informed consent
  • Willingness to submit a blood sample by venipuncture
  • Willingness to submit a second blood sample if necessary

Exclusion Criteria:

  • Age < 18 or > 75 years
  • Medical history of cancer other than cervical cancer, Non-islet-cell tumor hypoglycemia, Growth hormone deficiency, Acromegaly, Hepatoma, inflammatory disease in addition to confirmed CIN and cervical cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371695

Locations
United States, Georgia
Georgia Health Sciences
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Onconix, Inc
  More Information

No publications provided

Responsible Party: Sharad A. Ghamande, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01371695     History of Changes
Other Study ID Numbers: onc11-03-164
Study First Received: June 9, 2011
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Onconix, Inc:
IGF-II levels

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions

ClinicalTrials.gov processed this record on May 16, 2013